Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass
|ClinicalTrials.gov Identifier: NCT01144585|
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Lung Injury||Procedure: remote ischemic preconditioning and postconditioning Procedure: Control||Not Applicable|
Cardiopulmonary bypass(CPB) can cause lung function deterioration through various mechanisms. Lung parenchymal tissue ischemia resulted by pulmonary atelectasis and decreased bronchial circulation during CPB is one of the reasons. There were few studies reported that RIPC and RIPoCcan benefit lung function of children or infant after CPB, but studies about adults are still lacking.
The purpose of this study is to evaluate effect of RIPC and RIPoC on the lung function after CPB.
Patients will randomly allocated either in study group or control group. Study group will receive RIPC and RIPoC maneuver before and after CPB. Control group will have same automated cuff around their arm but it will not activated. Care givers will be blinded whether the automated cuff is on or not.
We will compare pulmonary parameters (PaO2/FiO2, dynamic and static compliances, Intrapulmonary shunts, etc.) between study group and control group, and check levels of plasma cytokines(IL-4, IL-8, IL-10, TNF-alpha) till 24hr after the operation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Ischemic-reperfusion Injury During Cardiopulmonary Bypass - Substudy of NCT00997217|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
those who receive RIPC and RIPoC before and after CPB
Procedure: remote ischemic preconditioning and postconditioning
RIPC is done before the use of CPB. It consists of 4 cycles of 5 minutes inflation of pneumatic cuff to 200 mmHg and deflation for 5 minutes. RIPoC is exactly same procedure done "after" CPB.
Placebo Comparator: Control
this group have same pneumatic cuff around their arm, but it is not inflated.
This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery
- arterial partial pressure of oxygen divided by fraction of inspired oxygen [ Time Frame: within 24hr after the surgery ]follow up PaO2/FiO2 during operation and after the opreation for 24 hours
- plasma cytokines [ Time Frame: within 24hr after the surgery ]follow up plasma IL-6, IL-8, IL-10, TNF-alpha levels during the surgery and within 24hr after the surgery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144585
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Study Director:||YunSeok Jeon, MD||Seoul National University Hospital|